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Clinical Trials in Australia / NCT05611671
Active, not recruiting Phase 2

A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

NCT05611671 · tracked via the Priya Life Science Australia tracker
Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Phase
Phase 2
Started
2022-11-21
Last updated
2025-12-15

Condition(s) studied

Inflammatory Bowel DiseasesColitis, Ulcerative

Investigational drug(s) / intervention(s)

MORF-057 →Placebo

MORF-057: MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Placebo: Matching placebo (identical appearance to MORF-057) administered orally.

Study summary

This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening * Has evidence of UC extending at least 15 cm from the anal verge * Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase \[JAK\] antagonists, or sphingosine-1-phosphate \[S1P\] receptor agonists) * Subject has no prior exposure to approved or investigational anti-integrin therapies * Agrees to abide by the study guidelines and requirements * Capable of giving signed informed consent Exclusion Criteria: * Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease * Has positive findings on a subjective neurological screening questionnaire * Has a concurrent, clinically significant, serious, unstable comorbidity * Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors * Participation in any other interventional study or received any investigational therapy within 30 days * Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057 * Unable to attend study visits or comply with study procedures

Primary outcome measure(s)

  • Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS) — Week 12
    * The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease. * Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of \< or =1; and an endoscopy subscore of \< or =1 without friability.

Trial sites (102)

FacilityCityRegionStatus
Arizona Digestive Health - Sun City Sun City Arizona
Gastro Care Institute Lancaster California
TLC Clinical Research Inc. Los Angeles California
Innova Clinical Trials Coral Gables Florida
Eminat, LLC - Miramar Miramar Florida
Robert Wood Johnson University Medical School New Brunswick New Jersey
Great Lakes Gastroenterology Mentor Ohio
The University of Texas Health Science Center at Houston Houston Texas
Blacktown Hospital Blacktown Australia
Concord Repatriation General Hospital Concord Australia
Royal Brisbane and Women's Hospital Herston Australia
Fiona Stanley Hospital Murdoch Australia
Mater Adult Hospital Brisbane South Brisbane Australia
Order Hospital Linz Ltd. - Hospital of Sisters of Mercy Linz Austria
Salzburg Regional Hospital Salzburg Austria
Medical University of Vienna Vienna Austria
Medical Center "Rusemed" EOOD Rousse Bulgaria
University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic" Sofia Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda Sofia Bulgaria
Second Multiprofile Hospital for Active Treatment - Sofia Sofia Bulgaria
PreventaMed, s.r.o. Olomouc Czechia
Clinoxus s.r.o., Outpatient Clinic Budejovicka Prague Czechia
LV Venter OU Pärnu Estonia
OU Innomedica Tallinn Estonia
East Tallinn Central Hospital Tallinn Estonia
West Tallinn Central Hospital Tallinn Estonia
University of Tartu Tartu Estonia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet Nice France
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC Tbilisi Georgia
Curatio, Jsc Tbilisi Georgia
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center Tbilisi Georgia
LTD Aversi Clinic Tbilisi Georgia
Medical Center "CITO" Ltd. Tbilisi Georgia
LTD The First Medical Center Tbilisi Georgia
Charite - University Hospital Berlin Berlin Germany
Krankenhaus Waldfriede Berlin Germany
University Hospital Schleswig-Holstein Kiel Germany
University Hospital Ulm Ulm Germany
Semmelweis Medical University Budapest Hungary
Semmelweis University, Department of Internal Medicine and Haematology, Division of Internal Medicine and Gastroenterology Budapest Hungary

+ 62 more sites — see the full list on the official registry below.

More Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) trials in Australia

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease Recruiting

Other trials for the same condition

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease Recruiting
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis Recruiting
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD Enrolling by invitation
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants Recruiting
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05611671 on ClinicalTrials.gov ↗ ← All trials in Australia